UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044274 |
|---|---|
| Receipt number | R000050565 |
| Scientific Title | Efficient oxygen administration method to subjects wearing surgical masks |
| Date of disclosure of the study information | 2021/05/20 |
| Last modified on | 2021/10/16 14:10:02 |
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Basic information
Public title
Efficient oxygen administration method to subjects wearing surgical masks
Acronym
Efficient oxygen administration method to subjects wearing surgical masks
Scientific Title
Efficient oxygen administration method to subjects wearing surgical masks
Scientific Title:Acronym
Efficient oxygen administration method to subjects wearing surgical masks
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate an efficient oxygen administration method in combination with a surgical mask.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
With the concentration stable, the difference in the numerical value of the oxygen concentration in the exhaled breath is the primary endpoint.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oxygen is administered by three methods: 1. administration from above the surgical mask with a face mask, 2. administration from under the surgical mask with a face mask, and 3. administration from under the surgical mask with a nasal cannula.
The order is 1, 2, 3
Interventions/Control_2
The order is 1, 3, 2
Interventions/Control_3
2, 1, 3
Interventions/Control_4
2,3,1
Interventions/Control_5
3,1,2
Interventions/Control_6
3,2,1
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
People with a history of respiratory illness
Smoker
COVID-19 patient
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | shigeru |
| Middle name | |
| Last name | saito |
Organization
Gunma University Hospital
Division name
Anesthesiology
Zip code
371-8511
Address
3-39-15,syowa town maebasi city gunma
TEL
027-220-8698
ymatsuijournal@aoi.com
Public contact
Name of contact person
| 1st name | yusuke |
| Middle name | |
| Last name | matsui |
Organization
Gunma University Hospital
Division name
Anesthesiology
Zip code
371-8511
Address
3-39-15 Showamachi , Maebashi City, Gunma Prefecture
TEL
0272208698
Homepage URL
ymatsuijournal@aoi.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital
Address
3-39-15 Showamachi , Maebashi City, Gunma Prefecture
Tel
0272208740
ciru_hitotaisho-irb@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00540-021-02998-6
Number of participants that the trial has enrolled
25
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 20 | Day |
Last modified on
| 2021 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050565
